BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER HEAD 28 12/14

    MDR report key: 3940595 · Received June 25, 2014

    Report

    Report Number
    9613350-2014-03658
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2010
    Report Date
    June 9, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. NEITHER THE SURGICAL REPORT NOR X-RAY PICTURES WERE NOT PROVIDED FOR REVIEW ALTHOUGH THE LOT NUMBER WAS RECEIVED FOR THE DEVICE AND THE DEVICE HISTORY RECORDS WAS REVIEWED AND FOUND TO BE CONFORMING. WHILE THE CAUSE OF THIS SPECIFIC EVENT COULD NOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, ONCE THE DEVICE IS RECEIVED AND INVESTIGATED AND THE RESULT OF THE INVESTIGATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A HIP REPLACEMENT ARTHROPLASTY ON (B)(6) 2013. DUE TO REPEATED DISLOCATION (SIX TIMES IN A SPAN OF 5 MONTHS IN VIVO), THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014. DURING SURGERY TRACES OF METAL WERE FOUND ON THE CERAMIC HEAD. CUSTOMER IS MAINLY INTERESTED IN THE METAL TRACES AND ITS EFFECTS RATHER THAN THE CAUSE FOR THE DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369861 BIOLOX DELTA CER HEAD 28 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH 2701218

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R